Status:

COMPLETED

Benign/Malignant Pulmonary Nodule Classification Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)

Lead Sponsor:

Geneplus-Beijing Co. Ltd.

Collaborating Sponsors:

Beijing Hospital

Emergency General Hospital

Conditions:

Pulmonary Nodule, Solitary

Whole-genome Methylation Sequencing

Eligibility:

All Genders

20-75 years

Brief Summary

Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned. The popularization of chest CT (electronic computed to...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed by chest CT;
  • The nodules are single or multiple, suspected to be malignant, and have the indication of surgical resection;
  • Patient accept imaging evaluation without advanced lung tumors and metastases;
  • The location of the nodule in the lung is within the reach of lung biopsy under bronchoscope;
  • provide the collected clinical data needed by the research;
  • Patients have the ability to follow the planned schedule and actively cooperate to return to the hospital for regular clinical visits.
  • Exclusion criteria:
  • Unwilling to accept the invasive examination and treatment of this study;
  • Contraindication of tracheoscopy;
  • Consider that the pulmonary nodules are metastatic tumors or unresectable advanced lung cancer;
  • Those who cannot tolerate resection of pulmonary nodules;
  • Accompanied by other malignant tumors;
  • In the judgment of the researcher, the patient also suffers from other serious diseases that may affect the accuracy of the test;
  • Those who cannot accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT);
  • Any other illness, social / psychological problems, etc. are judged by the researcher to be unsuitable for participating in this study.

Exclusion

    Key Trial Info

    Start Date :

    July 1 2023

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2025

    Estimated Enrollment :

    158 Patients enrolled

    Trial Details

    Trial ID

    NCT05415670

    Start Date

    July 1 2023

    End Date

    August 1 2025

    Last Update

    September 4 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Emergency general hospital

    Beijing, Beijing Municipality, China, 100028

    2

    Beijing hospital

    Beijing, Beijing Municipality, China, 100730